AccessGUDID - DEVICE: CPS DIRECT™ (05414734218313)

GUDID

Device Identifier (DI) Information

Brand Name: CPS DIRECT™
Version or Model: SLII
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DS2C017
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734218313
Issuing Agency: GS1
Commercial Distribution End Date: March 28, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

Device Description: Slittable Outer Guide Catheter

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58865	Vascular catheter introduction set, nonimplantable	A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	CATHETER, PERCUTANEOUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092075	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -5 and 50 Degrees Celsius
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit
Handling Environment Temperature: between -5 and 50 Degrees Celsius
Special Storage Condition, Specify: Store in a cool, dark, dry place. Keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 9 French
Length: 54 Centimeter

Device Record Status

Public Device Record Key: 1e83e5ff-76f0-49a0-a1c0-abb2a965440a
Public Version Date: October 28, 2024
Public Version Number: 7
DI Record Publish Date: January 27, 2017